New oral lipid-lowering treatment approved by NICE

Bempedoic acid (Nilemdo) has been approved for routine NHS prescribing with ezetimibe to treat primary hypercholesterolaemia or mixed dyslipidaemia when statins are unsuitable.

NICE has approved a new treatment option for lowering LDL-C, a leading risk factor for cardiovascular events. | GETTY IMAGES
NICE has approved a new treatment option for lowering LDL-C, a leading risk factor for cardiovascular events. | GETTY IMAGES

Bempedoic acid with ezetimibe is recommended as an option for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet in adults for whom statins are contraindicated or not tolerated, and ezetimibe alone does not control LDL-C well enough. 

Bempedoic acid and ezetimibe can be given as separate tablets or a fixed-dose combination (Nustendi). Around 70,000 patients are thought to be eligible for the new treatment, which is being provided to the NHS at a discounted price under a commercial access agreement.

Oral treatment option

Commenting on the draft NICE guidance issued last month, professor Kausik Ray, professor of public health and honorary consultant cardiologist, Imperial College London, said: 'Until now, patients with hypercholesterolaemia who cannot tolerate statins have had limited treatment options to effectively reduce their LDL-C levels, which is a leading modifiable risk factor of cardiovascular disease. Today’s announcement is fantastic news for patients as it marks the first new oral treatment options for high cholesterol to be made available in over a decade.'

Availability of treatments such as these is essential in tackling cardiovascular disease, the leading cause of death in the UK. When it comes to heart health and cholesterol, there is no such thing as ‘too low LDL-C’, highlighting the importance of treatments for high-risk patients.'

Bempedoic acid inhibits ATP citrate lyase, an enzyme involved in cholesterol synthesis. In contrast to statins, which can cause myopathy and rhabdomyolysis, the action of bempedoic acid is liver-specific and the drug is inactive in skeletal muscle.

The efficacy of bempedoic acid was demonstrated in four randomised, double-blind, placebo-controlled trials involving 3623 adults with hypercholesterolaemia or mixed dyslipidaemia. 

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